Grifols Biologicals LLC
Form 483 issued May 3, 2024 · Los Angeles, California
- Inspection
- Apr 25 – May 3, 2024
- Investigator
- Peng Zhou
- Observations
- 2
- Pages
- 4
- FEI number
- 2080769
In short: On May 3, 2024, FDA issued a Form 483 with 2 observations to Grifols Biologicals LLC in Los Angeles, California (FEI 2080769) after an inspection that ran Apr 25 – May 3, 2024. The investigator was Peng Zhou. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.42(c)(10)(iv) (1×) · 211.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Peng Zhou
15 documents · 2019–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
The firmGrifols Biologicals LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Grifols Biologicals LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Grifols Biologicals LLC?
Peng Zhou is named on this Form 483, for the inspection of Apr 25 – May 3, 2024. Each investigator has a profile showing what they cite most.
When was Grifols Biologicals LLC inspected by FDA?
The inspection ran Apr 25 – May 3, 2024, and the Form 483 is dated May 3, 2024.
How do I get the full Form 483 for Grifols Biologicals LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.